Theme:
Advanced Clinical research and compliance in Pharmacoepidemiologic studies.

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Scientific Program

11th International Conference on Pharmacoepidemiology and Clinical Research, will be organized around the theme “Advanced Clinical research and compliance in Pharmacoepidemiologic studies.”

Pharmacoepidemiology Congress 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Pharmacoepidemiology Congress 2017

Pharmacokinetics, describes the process and mechanism it undergoes when a drug enters into, through, and out of the body,and the due time course of its absorption, distribution ,bioavailability , metabolism, and excretion. Pharmacodynamics is a major branch of Pharmacology, which is defined as the study of biochemical and physiological effects of drugs on the body. Effects of body includes, stimulating action, and depressing action, synergetic action.

Pharmacoepidemiology is a broad science involving uses and effects of drugs in larger domains of population. Pharmacoepidemiology is a bridging science spanning both pharmacology and epidemiology. Pharmacoepidemiology enhances the informative study on topics apparently related to Pharmacoepidemiology, Pharmacokinetics, Adverse drug reactions, Public health, Epidemiologic methods, Medication adherence and Drug safety. This topic serves as a unique forum dedicated to scientists to express their findings as research presentations on an array of Pharmacoepidemiology and Drug Safety. The aims of pharmacoepidemiology within the industry are essentially the same as those of pharmacovigilance regulatory agencies; that is to protect patients from unnecessary harm by identifying the adverse effects, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. Clinical research is a branch of health care science that enables the use of various medications, medical and clinical devices, equipments and medical products for diagnosis, and treatment regimens used for the treatment of human disorders and diseases.

Preclinical trials involves the assessment of potential therapeutic interventions in cells and animals. Clinical trials are the distinct procedures followed in development of new drugs. Clinical trials are the characteristic studies intended for the treatment of behavioral symptoms between a medical intervention and a health outcome. Clinical trials includes patient data, disease mechanisms, therapeutic interventions, epidemiology, clinical medicine, preclinical and clinical pharmacology, immunology, toxicological studies. Clinical trials involves experimental clinical trials comparing the new treatment replacing the placebo or existing alternative treatments and safety methodology using data from observation of patients treated in clinical.Clinical data is a key feature transforming basic research into medical care. The perfect outcome of clinical trials is minimize risks, extend benefits, and optimal use of an intervention of therapeutic drugs.

Track 4-1Designing of Trials: Pre-Clinical Studies and different phases of Clinical Trials

A clinical trial is an experiment conducted on human subjects to test the medical treatments .The entire procedure of this theoretical science or formal study of clinical trials , planning and analysis of experiments, surveys, and observational studies is guided by statistical analysis. Statistical analysis in clinical trials help in establishing an objective framework for conducting an investigation by placing data and theory on an equal scientific footing and designing clinical data production through experimentation and quantifying the influence of chance and also to estimate the systematic and random effects.

Track 5-1Drug Discovery and Drug Screening

Track 5-2Clinical Research and Statistics

Track 5-3ICH Guidelines for Clinical Research and its Statistics

Track 5-4Data Mining concepts and Techniques

Track 5-5Pharmacokinetics and Pharmacodynamics

Track 5-6SAS Programing in Clinical Research and Pharmacutical Industry

Drug Safety is the pharmacological science ensuring safety and related to the collection, detection, assessment, monitoring, and prevention of adverse side effects with pharmaceutical products. Pharmacotherapy or drug therapy is using a medication to treat disease. Drugs interact with receptors or enzymes in cells to promote healthy functioning and reduce or cure illness. It is employed to treat a range of behavioural symptoms, disorders and diseases. Safety monitoring in clinical trials involves collecting adverse events, laboratory investigations including the planning, execution, data analysis and reporting of safety information and details of the clinical examination of patients.

Pharma Risk Management was desgined as a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks of medicinal and therapeutic products including the assessment of the effectiveness of their clinical reactions, interventions and combination therapies. Drug industry need to promote companies in pharmacovigilance practice to use information technology and provide efficient softwares to implement the risk minimisation plans in drug development and manufacture . Pharmaceutical risk management monitors unlicensed, off labels and orphan drugs ,risk management labeling, regulatory decisions, legal protection, intellectual property, enforcement, marketing, and company reputation.

Adverse drug reactions is that unwanted harmful reaction or irritable side effect which is experienced after the administration of a drug or combination of drugs under normal conditions of use. Adverse drug reactions embrace rashes, jaundice, anemia, a decrease in the white white blood cell count, kidney damage, and nerve injury that will impair vision or hearing. Affected people is also allergic or supersensitized to the drug owing to genetic variations in the way their body metabolizes or responds to medicine.

A case report is a detailed report of the signs or symptoms of a disease or diagnosis, treatment, and follow-up of an individual patient upon treatment by a pharmaceutical product. It contains a profile of the patient. Case reports can play a relevant role in medical education and provide a structure for case-based learning. Case reports may be on unexpected association between diseases, disorders or unwanted symptoms. An unexpected event in the course of observing, treating a patient, possibilities of pathogenesis of a disease or an adverse effect.

Pharmacovigilance plays a key role in all phases of clinical trials, including the planning, execution, data analysis and reporting of safety information and also bears an important responsibility for the expedited reporting of individual cases and safety updates required for regulatory authorities. The concept of Pharmacovigilance and its Significance enhances the impact of healthcare management on patient welfare and public health. Pharmacovigilance legislation gives an outlook on the rules and regulations to follow in Pharmacovigilance practice. The Role of pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, detection and evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines. In addition, data from observational epidemiological studies are playing an increasingly important role.

Track 12-1Pharmacovigilance and Healthcare System

Track 12-2Pharmacovigilance Legislation

Track 12-3Role of Pharma Industries in the Improvement of Pharmacovigilance System

Databases contain professional assessment of the potential of drugs and permits the risk- profit analysis of medicinal products taking under consideration new and emerging information, within the context of additive data. These database offers programming of alerts for fast cases, follow-up cases and reports submission to fulfill regulative timeline compliance. Data sources of pharmacoepidemiological databases are CPRD (Clinical Practice Research Datalink), IMS Health Disease Analyzer databases,PHARMO,Vigibase and Eudravigilance. Pharmacoepidemiology research studies may involve either data collected prospectively for the purpose of the particular study i.e. primary data, or data that were already collected for another purpose – as part of administrative records or patient health care , which is called secondary data.

Regulatory affairs is developed to protect public health by controlling the safety and efficacy of medical devices and pharmaceutical drug products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc.

Clinical Pharmacy and Pharmacy Practice involves developing the professional roles of pharmacists and is the order of drug store which includes adding to the expert parts of drug specialists. It includes Disease-state management, Clinical drug interventions, Pharmacy professional development and pharmaceutical care, pharmaceutical compounding and health psychology, patient care, drug abuse prevention, prevention of drug interactions or minimisation of adverse events and drug incompatibility and community pharmacy.

The clinical trial industry is evolving in an ever growing pace with diversified and updated strategies in clinical research technologies and new clinical and experimental studies are being launched rapidly. Clinical trials play a prominent role in medicine development process, as they provide the best clinical data for the treatment of diseases and disorders. This track includes various research developments in the field of Herbal Medicines, dietary supplements and vetenary products.

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